Self-Anchoring Catheters and Methods of Use

ABSTRACT

Catheters for percutaneous applications are disclosed. The catheter according to example embodiments may comprise a substantially straight section, an anchoring section positioned proximal to the substantially straight section. The anchoring section can have a curvature for providing longitudinal traction with a tissue to anchor the catheter to the tissue and a pathway extending through the catheter for transporting fluids. The pathway may comprise a first section and a second section in fluid communication with each other, where the first section extends through the length of the straight section, and the second section extends through the anchoring section and has a curvature which mimics the curvature of the anchoring section.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims benefit of and priority to U.S. ProvisionalPatent Application No. 62/085,838, entitled “Self-Anchoring Cathetersand Methods of Use”, filed on Dec. 1, 2014, which is incorporated hereinby reference in its entirety.

TECHNICAL FIELD

Example embodiments relate generally to catheters, more particularly, topercutaneous catheters. The present disclosure relates, in particular,to the use of a curved anchoring section for anchoring catheters withintissues without the need of additional devices or dressings.

BACKGROUND

A wide variety of catheters can be inserted into patients for short-termand long-term use. These catheters can be inserted into different typesof anatomic structures including vascular structures (e.g. veins,arteries, cardiac chambers), body cavities and spaces (e.g. thoracic,pericardial, peritoneal, epidural, thecal) and visceral organs (e.g.stomach, intestines, bladder). They are used for various purposesincluding infusion of substances (e.g. fluids, medications, bloodproducts, nutritional), withdrawal of blood or other bodily fluids fordiagnostic or therapeutic purposes (e.g. drainage, decompression),monitoring of physiologic parameters (e.g. pressure, temperature) and asa conduit through which therapeutic or diagnostic instruments arepassed.

Catheters commonly used for percutaneous applications includePercutaneous Venous Catheters (PVCs) and Central Venous Catheters(CVCs). PVCs are inserted through the skin into a peripheral vein,usually in the arm, and are the most common means of delivering fluidsor medications into patients. CVCs are inserted through the skin into acentral vein and usually remain in place for a long period of time,especially when the reason for their use is longstanding. PVCs and CVCsare secured into positions utilizing various means. For example, CVCsare sometimes inserted in more critical locations, and the catheters aresutured to the skin and frequently have eyelets, suture guides or otherfeatures to facilitate suturing. Other catheters are secured usingsimple or elaborate taping schemes. There are a wide variety ofproprietary catheter anchoring devices being marked which uses a varietyof adhesives, straps and other mechanisms.

Catheter dislodgment is an issue for a variety of reasons. Inadvertentdislodgement of certain catheters such as CVCs, chest tubes, largearterial sheaths and others can lead to serious complications includingair embolism, pneumothorax, hemorrhage or even death. Furthermore,replacing dislodged catheters can expose patients to additionaldiscomfort, interfere with the therapeutic regimen or other care andlead to complications from the reinsertion procedure. The economicburden resulting from dislodged catheters or the various efforts andprotocols necessary to prevent dislodgement can be significant.

Accordingly, there is a need for catheters that can be anchored to theskin without a need for suturing, elaborate taping and/or additionalanchoring devices.

SUMMARY

Devices, systems and methods for anchoring a catheter are disclosedherein. According to embodiments illustrated herein, there is provided acatheter capable of self-anchoring without the use of additionalanchoring instruments. The catheter may include a substantially straightsection, an anchoring section positioned proximal to the substantiallystraight section, where the anchoring section can have a curvature forproviding longitudinal traction with the tissue to anchor the catheterto a tissue. The catheter may further include a pathway extendingthrough the catheter for transporting fluids or through whichinstruments may be inserted into a patient, where the pathway caninclude a first section and a second section in fluid communication witheach other. The first section can extend through the length of thestraight section, and the second section extends through the anchoringsection and having a curvature which mimics the curvature of theanchoring section.

In some embodiments, there is provided a catheter system including astraight section having a flexible portion capable of assuming apre-determined curvature configured to provide traction with a tissue.The system may also include a shaping member with a curved sectionhaving the pre-determined curvature for shaping the flexible portion ofthe straight section into the pre-determined curvature, and a pathwayextending through the length of the straight section for transportingfluids to and from the tissue, wherein when the shaping member iscoupled to the flexible portion the flexible portion assumes the shapeof the pre-determined curvature and the pathway may mimic thepre-determined curvature.

In some embodiments, there is provided a method for operating aself-anchoring catheter. The method may include inserting a catheterinto a tissue, the catheter having a substantially straight section, ananchoring section positioned proximal to the substantially straightsection and a pathway extending through the straight section, theanchoring section having a curvature for providing longitudinal tractionwith a tissue to anchor the catheter to the tissue and the pathwayconfigured to mimic the curvature of the anchoring section. The methodmay also include advancing the catheter in a rotating fashion, until theanchoring section gains traction with the tissue, and anchoring thecatheter using the traction created between the anchoring section andthe tissue.

In some embodiments, there is provided a method for manufacturing acatheter. The method may include inserting a straight section of thecatheter into a shaping member having a curved portion with apre-determined curvature, the straight section having a flexible portioncapable of being molded into the pre-determined curvature. The methodmay also include shaping the flexible portion of the straight section toassume the pre-determined curvature, and removing the straight sectionfrom the shaping member, wherein the flexible portion of the straightsection retains the pre-determined curvature.

BRIEF DESCRIPTION OF THE DRAWINGS

Illustrative, non-limiting example embodiments will be more clearlyunderstood from the following detailed description taken in conjunctionwith the accompanying drawings.

FIG. 1A illustrates a catheter with a helical shaped self-anchoringsection;

FIG. 1B and FIG. 1C illustrate a catheter with a rigid insert forshaping a portion of the catheter;

FIG. 1D and FIG. 1E illustrate a catheter with a jacket for shaping aportion of the catheter;

FIG. 2A and FIG. 2B illustrate a catheter system having a helical shapedself-anchoring section and an insertion needle for assisting theinsertion of the catheter system;

FIG. 2C and FIG. 2D illustrate a catheter with a flexible anchoringportion and a rigid insertion needle capable of straighten the flexibleanchoring portion;

FIG. 2E and FIG. 2F illustrate a catheter system with a flexibleanchoring section and a rigid insertion needle;

FIG. 2G and FIG. 2H illustrate a catheter system with a flexibleanchoring section inserted into a vessel layer;

FIGS. 3A-3F illustrate a catheter system having a helical shapedself-anchoring section being inserted into anatomic structures;

FIG. 4A illustrates a central vascular catheter having a helical shapedself-anchoring section;

FIG. 4B illustrates a central vascular catheter having a helical shapedself-anchoring section being inserted into an anatomic structure;

FIG. 5A illustrates a thoracic catheter having a helical shapedself-anchoring section;

FIG. 5B illustrates a thoracic catheter having a helical shapedself-anchoring section being inserted into an anatomic structure;

FIG. 6A and FIG. 6B illustrate catheters having threaded self-anchoringsections;

FIG. 7A and FIG. 7B illustrate a catheter having a threadedself-anchoring section being inserted into an anatomic structure;

FIG. 8A illustrate a central vascular catheter having a threadedself-anchoring section; and

FIG. 8B illustrate a central vascular catheter having a threadedself-anchoring section being inserted into an anatomic structure.

DETAILED DESCRIPTION OF THE EMBODIMENTS

Various exemplary embodiments will be described more fully hereinafterwith reference to the accompanying drawings, in which some exampleembodiments are shown. The present inventive concept may, however, beembodied in many different forms and should not be construed as limitedto the example embodiments set forth herein. Rather, these exampleembodiments are provided so that this disclosure will be thorough andcomplete, and will fully convey the scope of the present inventiveconcept to those skilled in the art. In the drawings, the sizes andrelative sizes of layers and regions may be exaggerated for clarity.Like numerals refer to like elements throughout.

It will be understood that when an element is referred to as being“connected” or “coupled” to another element, it can be directlyconnected or coupled to the other element or intervening elements may bepresent. In contrast, when an element is referred to as being “directlyconnected” or “directly coupled” to another element, there are nointervening elements present. Other words used to describe therelationship between elements should be interpreted in a like fashion(e.g., “between” versus “directly between,” “adjacent” versus “directlyadjacent,” etc.).

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by oneof ordinary skill in the art to which this inventive concept belongs. Itwill be further understood that terms, such as those defined in commonlyused dictionaries, should be interpreted as having a meaning that isconsistent with their meaning in the context of the relevant art andwill not be interpreted in an idealized or overly formal sense unlessexpressly so defined herein.

Embodiments of the present disclosure generally provide self-anchoringcatheters and catheter systems for percutaneous applications. Thevarious embodiments of the present disclosure can be used for infuse orwithdraw fluids from bodily tissues, and to provide short or long termvenous accesses.

FIG. 1 illustrates a catheter 100 in accordance with various embodimentsof the present disclosure. Referring to FIG. 1, the catheter 100 caninclude a hub 102 section and a pathway 108 extending through the lengthof the catheter 100. The hub 102, as illustrated, may be positioned at aproximal end of the catheter 100 and designed to be connected to a widevariety of instruments, such as but not limited to, an infusion source,a withdrawal mechanism, a monitoring device or serve as a portal ofentry for diagnostic or therapeutic instruments. To that end, the hub102 may be of any shape or dimension so long as it can be attached tothe desired instrument.

The catheter 100 may also include a catheter or body section 104configured for communicating with anatomic structures. The cathetersection 104 can be directly connected to the hub 102 where a firstsection 108 a of the pathway 108 may extend through the entire length ofthe catheter section 104. The overall length of the catheter section 104can vary to better accommodate the insertion of the catheter 100 intodifferent types of anatomic structures. In some embodiments, thecatheter section 104 may further include a tip located at a distal end112, where the catheter section 104 and the distal tip 112 can be placedat desired locations for transporting (i.e., delivering or withdrawing)fluids. In some embodiments, the catheter section 104 may besubstantially straight in nature for overcoming multiple layers oftissues of an anatomic structure. The catheter section 104 can thenplace the distal tip 112 at the desired locations, where fluids can bedelivered or withdrawn at the distal tip 112 and then through thepathway 108. To better assist the insertion and anchoring of thecatheter at the various types of anatomic structures, the cathetersection 104 may be constructed to be rigid, semi-rigid or flexible andmay possess one or more lumens designed for different types of venousapplications. In general, the catheter 100 and its various componentsmay be made from any material that is biocompatible, including, but notlimited to, plastic, metal or ceramic.

In some embodiments, as shown in FIG. 1, for anchoring the catheter 100at a surgical site, the catheter 100 can include an anchoring section106 designed to secure the catheter 100 onto a tissue without usingsutures, tapes or additional anchoring apparatuses. The anchoringsection 106 may be designed to be directly connected the hub section102, or in some embodiments, a proximal catheter section 116 may beplaced between the anchoring section 106 and the hub section 102, wherethe proximal catheter section 116 may be substantially straight innature and the length of the section 116 can vary to better accommodatethe anchoring and insertion of the catheter into different anatomicstructures. Fluids can be transported through the entire length of thecatheter 100, from the hub 102 to the distal tip 112, via the pathway108 which extends through the entire anchoring section 106.

Referring to FIG. 1, to anchor the catheter 100 at a tissue site, theanchoring section 106, in some embodiments, can be curved to assume acorkscrew like helical configuration, designed to anchor into tissuestructures. This helical structure can include a plurality of turnsspaced apart at certain pitch designed to create a traction force withsurrounding tissue. Each turns of the helical structure can in generalhave a width 106 w that is substantially similar to the diameter 104 wof the catheter section 104 or the rest of the catheter 100 for thatmatter. Dimensions and pitch distances of the anchoring section 106 canbe configured to optimize the traction between the helical turns and thetissue body. For example, the diameter or width 106 d of the helicalportion can be substantially larger than the opening created by thecatheter section 104 when the catheter is initially inserted into thetissue, thereby ensuring the turns of the helical anchoring section 106can be securely pushed against the surrounding tissues. It should beappreciated that the length provided to the anchoring section 106, insome embodiments, should be sufficient to optimize traction, and thatalthough a helical design is provided, other geometric designs can beimplemented, so long as such a design permits that anchoring section tobe advanced to secure the device in place. In some embodiments, for a 1mm diameter PVC, the anchoring section 106 can have about two to sixturns, the helix diameter can be about two to six times the catheterdiameter (e.g., about two to six mm), and the pitch between the turnscan be about two to four mm. During an anchoring process, as thecatheter 100 is inserted into a tissue, the catheter 100 may be rotatedclockwise or counter-clockwise until the anchoring section 106 can beplaced substantially underneath at least one layer of tissue (i.e., alayer of skin), such that the plurality of helical turns can generate atraction force sufficient with the tissue to resist a longitudinaldisplacement of the catheter 100. Leaving at least one helical turnproximal to the anchoring tissue allow the catheter 100 to not onlyresist dislodgement from a traction force but also prevents the catheter100 from advancing further into the patient from a pushing force. Itshould be appreciated that the anchoring section 106 can be of any shapeor dimension so long as it can create sufficient traction forces withthe surrounding tissues to resist against dislodgement. In someembodiments, once the catheter 100 is secured in place, fluids can betransported through the pathway 108, where a second portion 108 b of thepathway 108 may be designed to mimic the curvatures of the helicalportion, such that fluids flows through each turns within the helicalportion. The second section 108 b of the pathway 108 can be entirelyhoused within the turns of the helical portion and in directcommunication with the first section 108 a of the pathway 108. Theanchoring section 106 as shown in FIG. 1 effectively allows tissues tobe lodged between each turns of the helical portion, thereby optimizingthe traction force between the catheter 100 with the surroundingtissues. Furthermore, the length and diameter of the helical portion, aswell as the number of turns and the pitch distance between turns, can beoptimized to better anchoring the catheter in different anatomicstructures. It should be appreciated that although only one anchoringsection is provided, to the extent that certain applications arecontemplated, the device can be provided with multiple anchoringsections. The availability of multiple anchoring sections can assist insecuring the device across an area with different tissues. For example,a catheter may include two or more anchoring sections for anchoring thecatheter in two different anatomic layers (e.g., skin and fascia). Thehelical corkscrew like configuration of the anchoring section 106 can beformed in a variety of ways. In order to serve its anchoring role, theanchoring section 106 may be configured to resist straightening duringapplication of a traction force. As such, the anchoring section 106 maybe designed to possess some rigidity. In some embodiments the entirecatheter 100 may be substantially rigid, in which case the helicalanchoring portion 106 can be created as part of a single piece by shapemolding that segment using common techniques (e.g. bending around amandrel, heat shaping or fabricating it in that shape from the onset).In some embodiments where the distal straight portion of the catheter104 is substantially flexible, the device can be constructed from asingle piece by treating the helical portion in such a way to render itmore rigid or by altering the material as it is being created (e.g.during an extrusion). In some embodiments, the catheter 104 can becreated from multiple parts which render the distal straight portionsubstantially flexible and the proximal helical portion more rigid. Forexample, a relatively rigid insert 120, as illustrated in FIG. 1B andFIG. 1C, may be applied to the anchoring section 106 (which may beflexible) to create a helical shaped portion. Or as illustrated in FIG.1D and 1E, a jacket 122 with a helical shape can be applied to theanchoring portion 106 of the catheter to render the anchoring portion106 more rigid and also shape the anchoring section 106 into a helicalconfiguration.

For the purpose of better assisting the initial insertion into a tissue,the catheter 100 can be equipped with a distal tip 112 that may be sharpand pointed and designed to penetrate tissues. Or, in some embodiments,an integrated needle or an insertion kit can be used to firstlypenetrate the tissue and then guide the catheter 100 to the desiredanatomic location. FIGS. 2A and 2B are diagrams illustrating aninsertion needle 200 designed to be integrated with the catheter 100 foran initial penetration into a tissue. Referring to FIG. 2A, theinsertion needle 200 can include a proximal needle hub 202 that isconnectable to the hub section 102 of the catheter 100. The proximalneedle hub 202 can be connected to a substantially straight needlesection 204, where the needle section 204 may be of a diameter that isless than the diameter of the pathway 108, such that the needle section204 can be inserted through the pathway 108. The needle section 204 canfurther include a distal tip 206 that may be sharp and pointed anddesigned to pierce through tissues. Now referring to FIG. 2B, in someembodiments, a catheter system 220 can have the catheter 100 integratedwith the insertion needle 200 for percutaneous applications. In use, theentire needle section 204 can be fed through the catheter 100 at thecatheter's hub section 102, as illustrated in FIG. 2B, where the lengthof the insertion needle's 200 needle section 204 can be optimized suchthat when inserted through the catheter 100, the distal tip 206 of theneedle section 204 protrudes out of the catheter 100 just slightly. Toaccomplish this integration with the catheter 100 while still be able topierce through tissues (i.e., skins and vessels), the integration needle200 can consists of shape memory metal such as nitinol or spring metal,which possesses the necessary flexibility to travel through the helicalconfiguration, yet also stiff enough to penetrate various anatomicstructures.

During a catheter anchoring process, the catheter 100 can be firstlyinserted through a layer of skin and into an appropriate anatomicstructure with the integrated needle 200 until the anchoring section 106(i.e., helical portion) reaches the skin entry point. The catheter 100can then be rotated until all or most of the anchoring section 106became submerged underneath the skin. Subsequently, the catheter 100 canbe covered with a simple dressing, where the dressing and additionaltreatment of the entry point can be performed to prevent inadvertentrotation of the catheter 100. In this manner, for at least the reasonthat the diameter of the helical portion is substantially larger thanthe entry opening in the skin, the anchoring section 106 can resistdislodgement in longitudinal direction. In some embodiments, removingthe catheter 100 can include removing the dressing, rotating thecatheter 100 in the opposite direction of the insertion rotation untilthe helical portion is completely outside the tissue body and then slidethe remaining distal straight catheter section 104 out of the patient.

In some embodiments, as shown in FIG. 2C and FIG. 2D, the helicalanchoring portion 106 of the catheter 100 may be fabricated so that itis stiff enough to resist straightening under traction forces butflexible enough and possesses shape memory so that it may be straightenwhen a rigid insertion needle 230 is advanced through the catheter's 100lumen. In this embodiment, the catheter 100 and insertion needle 230assemble 240 may be provided to an operator just as a traditional devicewould. The portion of the catheter with helical shape memory (e.g.,anchoring portion 106) can be indicated by a different color or othermarkings so that the operator can know where the helical portion beginsduring the insertion process. As illustrated in FIG. 2D, when a rigidinsertion needle 230 is inserted through the anchoring section 106, theanchoring section 106 may be flexible enough to assume a substantiallystraight shape. FIG. 2E and FIG. 2F illustrate an exemplary embodimentof the catheter system presented in FIG. 2C and FIG. 2D. As illustratedin FIG. 2E, the anchoring section 106 may be sufficiently flexible toassume other geometrical configurations, and the anchoring section 106may be marked in a distinct color so an operator may know where thesection 106 begins and ends. In some embodiments, as illustrated in FIG.2F, a rigid insertion needle 230 may be applied to the catheter 100 tostraight out the anchoring section 106.

During a catheter anchoring process, as shown in FIG. 2G and FIG. 2H,the straight catheter/needle assemble 240 may be inserted through alayer of skin 242 and into an appropriate anatomic structure until themarked, but current straightened, helical portion 106 is near the skinentry point. When the needle 230 is removed and no longer straighteningthe helical portion 106, this portion 106 takes its helicalconfiguration based on shape memory. The helical portion 106 can theninserted through the skin 242 using the same rotational motion.

In some embodiments, the catheter system 220 as shown in FIG. 2B can beconveniently deployed in anatomic structures where blood vessels layclosely or far away from the skin layer. Firstly, a blood vessel can beidentified through direct visualization, palpation or using some imagingmodality. Subsequently, catheters such as peripheral vascular catheters(PVCs) integrated with anchoring sections that are similar to theanchoring section 106 described in FIG. 1 can be used for percutaneousapplications. FIGS. 3A-3C illustrate the catheter 100 being anchored inan anatomic structure 300 where the thickness of the subcutaneous tissuelayer 302 is sufficiently large to anchor a substantial portion of theanchoring section 106 within. For such anatomic structures, during acatheter anchoring process, to reach a vessel layer 304, the cathetersystem 220, where the insertion needle 200 is integrated within thecatheter 100, may need to firstly pierce through a layer of skin 306 anda layer of subcutaneous tissue 302 using the sharp distal needle tip206. Referring to FIG. 3A, the catheter system 220 can then be rotatedto induce the anchoring section 106 through the initial entry site andinto the subcutaneous tissue 302. Once at least a substantial portion ofthe anchoring section 106 can be positioned within the subcutaneoustissue layer 302, the insertion needle 200 can be withdrew from thecatheter system 220 by pulling the needle 200 out of the catheter 100 atthe hub section 102. Illustrated in FIG. 3B is the catheter 100 insertedinto the vessel layer 304 after the insertion needle 200 has beenremoved from the catheter system 220. Referring now to FIG. 3C, thecatheter 100 can be securely anchored at the subcutaneous tissue layer302 where the distal tip 112 is in contact with the vessel layer toinfuse or withdraw fluids.

Similarly, as illustrated in FIGS. 3D-3F, the catheter system 220 can bereadily deployed in an anatomic structure where the thickness of thesubcutaneous tissue layer 308 may be insufficient to anchor theanchoring section 106. Referring now to FIG. 3D, after the distal end112 and a portion of the catheter section 104 has penetrated through thesubcutaneous tissue 308 layer to reach the vessel layer 310, thecatheter system 220 may be rotated to induce a horizontal motion to thecatheter section 104 until a substantial portion of the anchoringsection 106 can be position within the vessel layer 310. The helicalportion of the anchoring section 106 can create a traction force withthe vessel layer 310, effectively securing the catheter 100 with in thevessel layer 310. FIG. 3E illustrate the catheter 100 being insertedinto the vessel layer 310 with the insertion needle removed. Referringnow to FIG. 3F, after the catheter 100 is securely anchored in place,the anchoring section 106 may be entirely or partially anchored into thevessel layer 310 depending on the topography of that particular anatomicstructure.

It should also be appreciated that the helical configuration can also beused on central vascular catheters as illustrated in FIG. 4A. Similar atraditional central vascular catheter, catheter 300 as illustrated inFIG. 4A can possess a proximal hub section 302 with one or more ports304 and a catheter portion with one or more lumens 408. The catheterportion can include a substantially straight proximal section 406, ahelical anchoring section 408 and a distal section 410. Similar to theperipheral vascular catheter 200, the helical anchoring section 408 canalso be rigid or semi-rigid, and an insertion of the central vascularcatheter 300 can be facilitated with an insertion needle or an insertionkit. In some embodiments, the central vascular catheter 300 can beinserted into an anatomic structure to reach a blood vessel asillustrated in FIG. 4B. An insertion kit can be used to assist theaccess to vessel 312, where a finder needle and a guide wire can be usedto advance the straight proximal section 406 off the catheter 300 intoposition. Subsequently, the catheter 400 can advance over the wire untilthe helical anchoring section 408 reaches the skin 414. The catheter 400can then be rotated until the helical anchoring section 406 iscompletely under the skin 414. In general, the subcutaneous tissue layer416 will be thick enough such that the helical anchoring section 408will not enter the vessel 412. Furthermore, to prevent inadvertentrotations, the catheter 400 can be optionally covered with steriledressings as necessary.

In some embodiments, the helical configuration can also be used onthoracic catheters or chest tubes, as illustrated in FIGS. 5A and 5B.Referring to FIG. 5A, a thoracic catheter 500 can possess the similarfeatures of the vascular catheter 400 but to be used in a pleural space504 (i.e., lung) to evacuate air and fluid or on occasion, infusetherapeutic agents. Due to the fact that the tip of the catheter 500often needs to be precisely positioned at a specific surgical location(e.g. at the thoracic apex), the catheter 500 may possess a particularlylong helical anchoring section 502 for gaining access to the desiredsurgical location across the subcutaneous tissue 506 and the pleuralspace 504. The insertion process can include firstly creating a smallskin incision, followed by creating a tunnel through the subcutaneoustissue 506 and into the pleural space 504, then advance the catheter(generally without a trocar) 500 through the small skin incision, androtate the catheter 500 until the helical shaped anchoring section 502can reside completely under the skin 502 and the catheter tip is locatedat the proper position.

In some embodiments, the self-anchoring feature of the percutaneouscatheters may be formed by screw-like threads which engages the skin andprevents dislodgement, as illustrated in FIGS. 6A and 6B. In many ways,this embodiment can be similar to that of the helical configuration. Thecatheter 600 as shown in FIG. 6A can include a proximal hub 602, astraight proximal section 504, a threaded anchoring section 606 followedby a straight distal section 608. Or as shown in FIG. 6B, the threadedanchoring section 606 can be contiguous with the proximal hub 602,eliminating the straight proximal section 604 of the catheter 600, wherethe threaded anchoring section 606 can be rigid, semi-rigid or flexible.In some embodiments, the width, pitch and number of turns of the threadscan be optimized to facilitate a better engagement with a wide range ofskin thicknesses.

It should be appreciated that the threaded anchoring sectionconfiguration can be applied to all percutaneous catheters including theperipheral vascular catheters and the central vascular catheters.

For example, FIGS. 7A and 7B are diagrams illustrating a peripheralvascular catheter 700 having a threaded anchoring section 702 inaccordance with an embodiment of the present disclosure. Referring toFIG. 7A, the anchoring section 702 can be directly connected to a hubsection 704 designed to function as an infusion source or a withdrawalmechanism. The anchoring section 702 can be designed to have threadsconfigured to anchor onto tissues. As shown in FIGS. 7A and 7B andsimilar to the insertion process illustrated in FIGS. 3A and 3B, afterthe catheter 700 has been inserted through a layer of tissue 708 (i.e.,skin) using an insertion needle 706, the catheter 700 can be rotated tobe entered through the opening provided by the insertion needle 706,where the anchoring section 702 can be threaded into the tissue layer708, thereby providing anchoring to the catheter 700.

In a similar fashion, central vascular catheters can also be equippedwith the threaded anchoring sections designed to provide anchoringwithin tissues. FIGS. 8A and 8B are diagrams illustrating a centralvascular catheter 800 in accordance with embodiments of the presentdisclosure. Referring to FIGS. 8A and 8B, the catheter 800 can includean anchoring section 802 equipped with threads designed to anchor ontotissues, where the anchoring section 802 can be directly connected to aproximal hub section 804 designed to be coupled to other instruments. Inuse, after an initial insertion into a tissue, the catheter 800 can berotated until the threaded anchoring section 802 can be threaded intothe tissue, thereby providing anchoring to the catheter 800, asillustrated in FIG. 8B.

It should be appreciated that although described as being helical indesign or threaded in design, the self-anchoring portion of the cathetercan be one of a helical design, a threaded design, any self-anchoringdesigns, or a combination thereof.

While the present disclosure has been described with reference tocertain embodiments thereof, it should be understood by those skilled inthe art that various changes may be made and equivalents may besubstituted without departing from the true spirit and scope of thedisclosure. In addition, many modifications may be made to adapt to aparticular situation, indication, material and composition of matter,process step or steps, without departing from the spirit and scope ofthe present disclosure. All such modifications are intended to be withinthe scope of the claims appended hereto.

What is claimed is:
 1. A catheter comprising: a substantially straightsection; an anchoring section positioned proximal to the substantiallystraight section, the anchoring section having a curvature for providinglongitudinal traction with a tissue to anchor the catheter to thetissue; and a pathway extending through the catheter for transportingfluids or to serve as a passageway for instruments, the pathwaycomprising a first section and a second section in fluid communicationwith each other, wherein the first section extends through the length ofthe straight section and the second section extends through theanchoring section and has a curvature which mimics the curvature of theanchoring section.
 2. The catheter of claim 1, wherein the substantiallystraight section further comprises a pointed tip for piercing throughtissues.
 3. The catheter of claim 1, wherein the curvature of theanchoring section is a helical structure with a plurality of turns. 4.The catheter of claim 1 further comprising a hub section positionedproximal to the anchoring section for providing coupling with a medicalinstrument.
 5. A catheter system comprising: a catheter having astraight section having a flexible portion capable of assuming apre-determined curvature configured to provide traction with a tissue; ashaping member with a curved section having the pre-determined curvaturefor shaping the flexible portion of the straight section into thepre-determined curvature; and a pathway extending through the length ofthe straight section for transporting fluids to and from the tissue,wherein when the shaping member is coupled to the flexible portion theflexible portion is shaped to assume the pre-determined curvature andthe pathway is configured to mimic the pre-determined curvature.
 6. Thecatheter system of claim 5, wherein the pre-determined curvature is ahelical configuration with a plurality of turns.
 7. The catheter systemof claim 5 further comprising an insertion needle removably insertedthrough the pathway for piercing through tissues.
 8. The catheter systemof claim 7, wherein the insertion needle includes a rigid portion forshaping the flexible portion of the straight section.
 9. The cathetersystem of claim 7, wherein the flexible portion of the straight sectionis substantially straighten when the insertion needle is insertedthrough the pathway but resumes its original geometrical configurationonce the insertion needle has been removed from the pathway.
 10. Amethod for operating a catheter comprising: inserting a catheter into atissue, the catheter having a substantially straight section, ananchoring section positioned proximal to the substantially straightsection and a pathway extending through the anchoring section, theanchoring section having a curvature for providing longitudinal tractionwith a tissue to anchor the catheter to the tissue and the pathwaymimicking the curvature of the anchoring section; advancing the catheterin a rotating fashion, until the anchoring section gains traction withthe tissue; and anchoring the catheter using the traction createdbetween the anchoring section and the tissue.
 11. The method of claim10, wherein the step of inserting a catheter further comprises couplingan insertion needle to the catheter for piercing the tissue.
 12. Themethod of claim 10, wherein the step of coupling an insertion needle tothe catheter further comprises inserting a rigid portion of theinsertion needle through the curvature of the anchoring section.
 13. Themethod of claim 12, wherein inserting the rigid portion of the insertionneedle straightens the anchoring section.
 14. The method of claim 12,wherein the step of anchoring the catheter further including removingthe insertion needle from the pathway.
 15. The method of claim 10,wherein the step of inserting a catheter further comprising pushing thecatheter until the substantially straight section reached a desirableanatomic location.
 16. The method of claim 10, wherein the step ofadvancing the catheter further including rotating the catheter until theanchoring section is substantially submerged in at least one layer oftissue.
 17. The method of claim 16, wherein the catheter furtherincludes a pathway extending through the catheter for transportingfluids, the pathway comprising a first section and a second section influid communication with each other, wherein the first section extendsthrough the length of the straight section, and the second sectionextends through the anchoring section and having a curvature whichmimics the curvature of the anchoring section.
 18. A method for forminga catheter comprising: coupling a straight section of a catheter with ashaping member having a curved portion with a pre-determined curvature,the straight section having a flexible portion capable of being shapedinto the pre-determined curvature and a pathway extending through thestraight section, wherein the pathway mimics the curvature of theshaping member; shaping the flexible portion of the straight section toassume the pre-determined curvature; and removing the straight sectionfrom the shaping member, wherein the flexible portion of the straightsection retains the pre-determined curvature.
 19. The method of claim18, wherein the shaping member is a rigid insert for shaping theflexible portion.
 20. The method of claim 18, wherein the shaping memberstays with the anchoring portion during catheter insertion.